Efficacy and Safety of Olaparib in Pretreated Patients With Measurable Colorectal Cancer, Stratified by Microsatellite Instability (MSI) Status

AstraZeneca33 enrolled

Overview

This study is being carried out to see if the new drug, olaparib (AZD2281), can effectively and safely treat advanced large bowel cancer. The primary goal of this clinical trial is to determine whether olaparib will have a beneficial effect on the patient's cancer by causing a response and increasing the time it takes for the cancer to progress.

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Colorectal Cancer

Interventions

olaparibDRUG

400 mg po bid continuously

Eligibility

Sex: ALLMin age: 18 YearsMax age: 130 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Patients will have measurable disseminated colorectal cancer that is incurable by surgery * Patients will have had tumor progression following standard combination front-line or second-line chemotherapy. * CRC patients who have relapsed or recurrent disease within six months after completing adjuvant or neoadjuvant chemotherapy Exclusion Criteria: * Previous treatment with PARP inhibitors, including olaparib. * Patients with symptomatic, uncontrolled brain metastases. * Patients receiving any chemotherapy, radiotherapy (except for palliative reasons), within 4 weeks from the last dose prior to study entry (or a longer period depending on the defined characteristics of the agents used). * Patients who are unable to swallow orally administered medication.

Locations (8)

Research Site

Los Angeles, California, United States

Research Site

Palm Springs, California, United States

Research Site

Aurora, Colorado, United States

Research Site

Newark, Delaware, United States

Outcomes

Primary Outcomes

Tumour Response

Tumour response is the number of patients who experienced complete or partial response at least once during the assessment period, according to the definitions of Response Evaluation Criteria In Solid Tumours (RECIST version 1.1)

Time frame: From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months

Secondary Outcomes

Progression Free Survival

Progression free survival is defined as the duration from first dose till objective progression or death. In absence of progression or death, the time is calculated from first dose till last evaluable scanning visit.

Time frame: From baseline, i.e. up to 28 days before first study drug dose, and then every 2 cycles (8 weeks) up to objective disease progression by RECIST, assessed up to 35 months

Overall Survival

Overall survival is defined as the duration from first dose till death from any cause. In absence of death, the time is calculated from first dose till the date subject last known to be alive

Time frame: Survival follow-up from first dose till death of the patient or till end of study in absence of death, assessed up to 35 months

Data from ClinicalTrials.gov

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